Still more Zantac MDL dismissal orders.
Today’s installment grants dismissal of the plaintiffs’ medical monitoring claims, and also sheds some light on the questionable factual basis of everything being asserted in this MDL. As we’ve pointed out in our prior posts (such as this one), plaintiffs allege that the active ingredient in this drug could break down into an alleged carcinogen, particularly in warm or moist environments. However, N-Nitrosodimethylamine (“NDMA”), the allegedly harmful breakdown product at issue, is ubiquitous, and anyone who consumes bacon, beer, or cheese has likely been exposed over the years to higher doses from these other sources.
That matters for medical monitoring claims, as In re Zantac (Ranitidine) Products Liability Litigation, 2021 WL 2682659 (S.D. Fla. June 30, 2021), demonstrates. This Zantac decision booted most of a “master” class action complaint seeking medical monitoring and other purported economic losses. Plaintiffs sought to create a litigation castle in the sky (no less than 638 counts) with a great many would-be classes (divided up by state and by defendant) in five general categories: medical monitoring against branded manufacturers of prescription products; medical monitoring against branded manufacturers of over-the-counter (“OTC”) products; medical monitoring against generic manufacturers; medical monitoring against “store brand” sellers; and medical monitoring against “store brand” manufacturers. Id. at *3.
Since many members of these putative classes undoubtedly took more than one of these products, some going back more than two decades, and many were without prescription, how plaintiffs would prove their respective exposures to each – an essential element of any medical monitoring claim − strikes us as entirely speculative.
Secondarily, plaintiffs filed a “consolidated, amended consumer economic loss class action” described as an action by 180 named plaintiffs:
in their individual capacities and on behalf of numerous classes . . . under various state laws stemming from the Defendants’ sale of prescription-strength ranitidine for approximately forty states. Additionally, the Plaintiffs bring state class actions under approximately forty-three states’ laws for the Defendants’ sale of OTC ranitidine.
Id. at *4 (footnote omitted). Another castle in the clouds. We addressed the RICO aspects of this complaint here.
The preliminary skirmish on medical monitoring was whether two of the states as to which plaintiffs chose to bring claims – Indiana and Montana – would recognize a medical monitoring recovery by otherwise uninjured plaintiffs. Unfortunately, a nearly 30-year-old intermediate appellate court in Indiana had allowed such a claim, Gray v. Westinghouse Electric. Corp., 624 N.E.2d 49 (Ind. App. 1993), so the defendants lost on Indiana. 2021 WL 2682659, at *8. There being no equivalent support for medical monitoring in Montana, the court went with Erie conservatism and dismissed all the Montana monitoring claims with prejudice for failure to state a claim. Id. at *9 (refusing to “expand Montana law in the manner that the Plaintiffs suggest”; “On no interpretation of Erie of which we are aware may a decision by a state trial court be credited as determining the law of the state”) (citation and quotation marks omitted).
The real fun begins with consideration of the “plausibility” of plaintiffs’ medical monitoring claims.
Although “[t]he law of medical monitoring varies across jurisdictions,” id. at *10, such “non-traditional torts” share several essential elements in common: (1) exposure to a hazardous substance above normal levels; (2) in a threshold amount; (3) sufficient to create a significant increase in risk of a serious health condition; (4) for which medical monitoring exists that would facilitate early exposure; (5) which is different than routine medical testing anyone should get. “[S]ome states require that testing procedures exist to detect diseases early, while others do not.” Id. (discussing, inter alia, Florida law).
Plaintiffs’ claims failed, first, on the issue of “significantly increased risk.” Id. at *11-12. The “significant risk” analysis “raises two distinct questions.” Id. at *12. “First, . . . how much NMDA must a Plaintiff be exposed to before the Plaintiff has a significantly increased risk of cancer? Second, how much NDMA exposure have the Plaintiffs alleged?” Id. Plaintiffs’ verbose and Brobdingnagian complaint botched both prongs. “Plaintiffs have failed to clearly plead just how much exposure the Plaintiffs received and how much exposure is needed to warrant the remedy of medical monitoring.” Id.
The basic question is how much exposure to NDMA is allegedly the threshold exposure for “significant” increased risks of “cancer.” Plaintiffs’ opposition papers used 3,000 nanograms (“ng”), but they did not clearly allege that as the threshold exposure for a “significant” cancer risks in the complaint itself. Id. Instead, they “alleged that the consuming of 96 ng each day, for seventy years, results in a .001% increase in the risk of cancer.” Id. (emphasis added).
.001%? Give us a break. That’s entirely trivial. 1% is one in a hundred – so .1% is one in a thousand; .01% is one in ten thousand, and .001% is one in one-hundred thousand. These plaintiffs are seeking test 100,000 people on the off-chance of detecting one early cancer, with no assurance that such testing would actually improve anyone’s prognosis. And seventy years? Zantac didn’t come on the market until 1981, and not one of the now over 20 Zantac MDL opinions mentions anything about pediatric use.
Nor do plaintiffs’ allegations account for “cancer” being anything but monolithic, but rather a catch-all term for a variety of metastatic conditions having different etiologies and tests for detection.
Only in an MDL would plaintiffs even think about making such absurdly overbroad allegations. We offer, in contrast, our post, here, on punitive damages, requiring a “substantially certain” risk of harm. The Zantac claims aren’t even in the same ballpark.
Fortunately this MDL judge doesn’t seem to be drinking the plaintiffs’ Kool-Aid. Understandably the Zantac court required that “if the Plaintiffs equate a .001% increased risk with a significantly increased risk, then the Plaintiffs should clearly make that argument.” Id.
The next point was how much NDMA exposure was actually alleged − from background consumption and allegedly from taking Zantac or generic ranitidine. Once again, plaintiffs’ complaint fell short. Like we’ve pointed out in our posts, “every human being consumes NDMA through eating, drinking, and even breathing.” Id. According to studies plaintiffs themselves cited, the background rate – “daily NDMA consumption levels” on the high end, was 510 ng/day in one study, 191 ng/day in another, and 179 ng in a third. Id. That’s from nearly two, to over five, times as much as the 96 ng/day rate that plaintiffs impliedly asserted could cause “significant” cancer risk (if taken daily for a lifetime). Id. In other words, background NDMA exposure significantly exceeds exposure allegedly caused by defendants’ products, according to plaintiffs’ own studies.
And it gets worse.
Plaintiffs’ argued for a purported “3,000 ng of NDMA per-dose” – that is, per Zantac/ranitidine pill – but that allegation was nowhere to be found in their 2,192-page complaint. Id. at *4.
And it gets worse.
The chief study cited in plaintiffs’ complaint about alleged per-pill amounts of NDMA simply is no more. “[A] red retraction notice appears on the top of the study.” Id. (emphasis added). As the opinion dryly puts it, “[i]f the Plaintiffs’ position is that the Court may conclude that the Plaintiffs have plausibly alleged a claim for medical monitoring based upon a retracted study, the Plaintiffs should clearly argue and explain that position.” Id.
A second, even wilder, estimate – that each pill contained over 2,000,000 ng of MDMA – also bore no relationship to reality:
[T]he Court has been able to locate an allegation that each [drug] dose contained over 2,000,000 ng of NDMA. That number [was . . . arrived at . . . by heating [the drug] to 266 degrees Fahrenheit. Pursuant to the Plaintiffs’ allegations, however, the temperature of the human body is 98.6 degrees, not 266 degrees.
Id. (emphasis added). Even during the hottest day in the hottest place (Death Valley) in the recent record heat waves, the temperatures did not get within 100° of that temperature. For obvious reasons, “the Court does not conclude that a test utilizing 266 degrees of heat plausibly establishes a significantly increased risk of cancer.” Id.
Another hypothesis was that the drug breaks down in the stomach at body temperature (≈98.6°F) in the presence of food containing sodium nitrite. Is that biologically plausible? In a word, no.
In the absence of an explanation or context from the Plaintiffs, the Court endeavored to understand what, mathematically and scientifically, [the necessary amount] of sodium nitrite means. The Court attempted to perform its own mathematical calculations to discern the amount of bacon necessary to collect [that amount] of sodium nitrite in the human stomach. The Court’s own calculations estimated the amount of bacon to be necessary at around 25 pounds.
Id. at *15 (footnote omitted). That’s another purported per dose calculation. So, to reach the threshold exposure, all a putative class member would have to do is take each pill with food – 25 pounds of bacon per pill – and repeat each day for 70 years.
Although this scientific discussion takes place in Zantac in connection with estimating increased risk in the context of medical monitoring, the larger picture is also emerging – the plaintiffs’ increased risk calculations are generally unrealistic and wildly inflated. It will be very difficult for them to get out of that hole. The court suggested that they begin that attempt by “provid[ing[ context and explanation” for their numbers in any amended complaint that they subsequently file. Id.
Good luck (not).
Because “[f]ourth and finally, the Court has been able to locate allegations about the amount of NDMA in [the drug] from tests performed by the FDA.” Id. at *15. The FDA’s unbiased testing once again severely undercuts plaintiffs’ numbers while simultaneously demonstrating variability that should be fatal to any putative class action:
The amount of NDMA found in the [the drug] was not equal across the Manufacturing Defendants. . . . One Defendant’s [product] tested as having zero. . . . Even if the Court were to utilize the highest amount of NDMA found by the FDA (360 ng) and assume that every Defendant’s ranitidine had that much NDMA, that number is still an order of magnitude lower than the 3,000 ng number argued in the Plaintiffs’ response.
The Court addresses one final point about the FDA’s findings. In the FDA’s own words, the “NDMA levels FDA found are similar to the levels a consumer would expect to be exposed to when eating common foods like grilled and smoked meats.”
Id. (citations omitted) (emphasis added). As mentioned above, medical monitoring in any state requires significant exposure above background levels.
And we’ve only covered the problems with plaintiff’s allegations concerning exposure per pill.
Plaintiffs likewise fail to allege plausibly the “frequency” of their exposures – that is, how often they took pills. The Zantac complaint vaguely references “therapeutic doses.” Id. at *16. What’s that? Plaintiffs’ pleading ensures that nobody knows. They allege only that individual “[p]laintiffs “ingested [the drug] at various times as part of their treatment.” Id.
Very enlightening. That their 2,000+ page complaint lacks such basic information strongly suggests they can’t plead it – at least not in any form that could conceivably support class-wide proof.
There is no allegation as to the frequency of use, nor is there a reference to “therapeutic dosages.” The Plaintiffs’ alleged class definitions similarly do not assist the Court, because the Plaintiffs define the class as being anyone “who used” ranitidine without qualification.
Id. at *16. This is why we headlined this post with the “wheels coming off” the Zantac litigation – a combination of self-evidently fabulist general dosage calculations and utterly absent individual information concerning frequency of use. Plaintiffs’ allegations wouldn’t even pass muster in asbestos litigation.
They get to try again, but this will be their third round of pleadings. We hope “strike three” means “yer out”:
Plaintiffs may, of course, plead a substantial increase in the risk of cancer in whatever way they deem best, including through avenues other than NDMA exposure and NDMA frequency. The Court’s ruling is merely that, as pled, the Court cannot conclude that the Plaintiffs have plausibly alleged a substantial increase in the risk of cancer.
Id. at *17.
On top of all this, plaintiffs’ allegations as to the current existence of a “diagnostic testing regime” that supposedly would help the plaintiff class get early cancer detection screenings was not plausibly factually alleged and thus got TwIqballed. “The Plaintiffs’ allegation amounts to a ‘naked assertion devoid of further factual enhancement.’” Id. (quoting Iqbal itself). “[T]he Plaintiffs’ allegations are merely a recitation of the required elements.” Id. at *18.
One wonders what plaintiffs did plead in all of these 2,000+ pages, since it certainly wasn’t the necessary elements of medical monitoring.
Beyond medical monitoring, plaintiffs re-raised their failure-to-report allegations involving the FDA, which the court had already indicated were preempted in an opinion we discussed previously. We are reminded of a quote attributed (probably falsely) to Einstein: “The definition of insanity is doing the same thing over and over again and expecting different results.”
In the Court’s Order Granting in Part and Denying in Part the Branded Defendants’ Rule 12 Partial Motion to Dismiss Plaintiffs’ Three Master Complaints as Preempted by Federal Law, the Court concluded that the Plaintiffs’ claims for failure to warn consumers through the FDA are pre-empted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), for the reasons that the Eleventh Circuit Court of Appeals outlined in Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330 (11th Cir. 2017). The Court dismisses the claims with prejudice for that reason. In light of this ruling, the Court need not address arguments directed to the viability of the claims under state law and pleading deficiencies.
Zantac, 2021 WL 2682659, at *21.
As to the economic loss claims, plaintiffs were held to have Article III standing by reason of claimed economic injury. Id. at *25-28. Bexis, being a veteran of the Engle wars, has generally mixed feelings about standing arguments of this sort, because success in denying constitutional standing in federal court has led plaintiffs in some cases to try again in state court, without the defendant having any way to remove (there being no standing) to federal court.
Significantly, the court required plaintiffs asserting claims concerning prescription (as opposed to OTC) products to plead facts satisfying the elements of the learned intermediary rule. That should be fatal to any class action, since learned intermediary rule issues are inherently individualized.
The Defendants argue that the Plaintiffs’ failure-to-warn claims concerning prescription [products] fail as a matter of law under the learned intermediary doctrine. This is so because Plaintiffs do not allege that their physicians were inadequately warned about the alleged cancer risk associated with [the drug], or that their physicians would have made different prescribing decisions if they had been warned.
Id. at *28 (citations and quotation marks omitted). Once again, the plaintiffs’ already massive complaint was inadequate.
[T]he Court dismisses the Plaintiffs’ prescription-based claims [some 700 separate counts] without prejudice, and with leave to plead allegations that are specifically relevant to the learned intermediary doctrine. This scope of leave is not broad, but rather extremely narrow and specific as to this discrete issue.
Finally, the court clears the way for the defendants to challenge other aspects of the plaintiffs’ economic loss complaint, specifically the applicability of “safe harbor provisions” in the consumer protection statutes of 24 states, and “[r]elatedly, [that] the Plaintiffs’ consumer protection, implied warranty, and unjust enrichment claims are barred, since the Defendants’ FDA-approved labels were presumptively lawful and not false or misleading.” Id. at *29. Also defendants may challenge plaintiffs’ unjust enrichment claims on the next go-round on various state-law grounds. Id.
Defendants will have to “seek leave of Court” to do this at some “later stage of the litigation,” id., and we wonder if it will ever be necessary. That’s because we’re not at all sure how many “later stages” of litigation there will be. As discussed, the biggest takeaway from this edition of the Zantac chronicles is the evident scientific bankruptcy of the plaintiffs’ risk and causation positions.